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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00286-1
Product Name/Description Bard ConQuest PTA Balloon Dilatation Catheter
(Intended for use in Percutaneous Transluminal Angioplasty of the femoral, renal and iliac arteries)

Product Codes: CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124

Lot Numbers:REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575

ARTG Number: 137802
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 27/03/2015
Responsible Entity Bard Australia Pty Ltd
Reason/Issue Bard Peripheral Vascular (BPV) has identified that the product code / lot number combinations affected may be at risk of having deflation related issues.

In the event a PTA balloon will not deflate, immediate intervention is required in order to deflate the balloon and allow for continued blood flow. In many cases, this can be accomplished percutaneously by inserting a device (i.e., guidewire or sheath) to the PTA balloon and puncturing the balloon and/or a sheath, allowing its withdrawal. This can usually be completed through the same vascular access, however, may require additional access. In the event a PTA balloon cannot be deflated while in the extremities (i.e., superficial femoral artery or AV fistula), it may be possible to insert a sterile needle through the skin and reach the balloon and pierce it in order to deflate it. In the event a percutaneous approach cannot successfully deflate the PTA balloon, an open surgical approach will be required.
Recall Action Recall
Recall Action Instructions Customers are advised to remove any affected product from their shelves and contact Bard Australia Customer Service to arrange for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.
Contact Information 1800 257 232 - Bard Australia